Vestibular Rehabilitaion in Bilateral Vestibular Hypofunction

Sponsor
Istanbul Gedik University (Other)
Overall Status
Completed
CT.gov ID
NCT05676307
Collaborator
(none)
31
1
1
9.9
3.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the etiological factors that constitute bilateral vestibular hypofunction and to investigate the effect of vestibular rehabilitation in these patients.

The Caloric test and Video Head Impulse test were applied to evaluate the vestibular hypofunction picture of the patients who applied to Clinic with complaints of vertigo, dizziness and imbalance. Among these patients with BVH, those with vestibular symptoms, imbalance complaints and limited daily living activities were included in rehabilitation. In order to investigate the effectiveness of rehabilitation, oculomotor functions were evaluated using Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System, balance assessment was done with timed balance tests and quality of life assessment was performed with Dizziness Handicap Inventory.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Vestibular Rehabilitation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
ETIOLOGICAL FACTORS AND EFFECT OF VESTIBULAR REHABILITATION ON BILATERAL VESTIBULAR HYPOFUNCTION
Actual Study Start Date :
Jan 15, 2022
Actual Primary Completion Date :
Oct 23, 2022
Actual Study Completion Date :
Nov 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bilateral Vestibular Hypofunction

Vestibular Rehabilitation in Bilateral Vestibular Hypofunction

Behavioral: Vestibular Rehabilitation
Cawthorne Cooksey Based Vestibular Rehabilitation Exercises (Oculomotor exercise, Vestibulo-ocular Exercise, posture exercise, balance training, etc)

Outcome Measures

Primary Outcome Measures

  1. Evaluation of Oculomotor Activity (Saccade Frequency Level) [8 week]

    Oculomotor Function Level was evaluated with Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System. The name of this web-based system that supports VOR wient in the evaluation part of the vestibular software.sth oculomotor and optokinetic stimuli is Simulation of Vestibulo-Ocular Reflex Exercises (SVORE). This system includes Assessment and Rehabilitation departments. The maximum saccade frequency levels were determined with the measurements. For the evaluation of saccade eye movement, patient will be asked to focus on the objects on the screen.

  2. Quality of Life Assesment [8 weeks]

    The level of quality of life was evaluated with Dizziness Handicap inventory.The Dizziness Handicap Inventory (DHI), which evaluates the quality of life in vestibular diseases, was used in the study. This 25-item scale determines the emotional and functional outcomes of patients in vestibular system diseases as well as aggravating factors related to dizziness and impaired balance.

  3. Static Balance Tests [8 weeks]

    To evaluate the static balance of the patients; Length of standing in romberg, semitandem, tandem, standing on one leg, eyes open-closed positions were recorded in seconds with a stopwatch.

  4. Evaluation of Oculomotor Activity (Pursuit Frequency Level) [8 weeks]

    Oculomotor Function Level was evaluated with Simulation Of Vestibulo-ocular Reflex Exercises (SVORE) System. The name of this web-based system that supports VOR wient in the evaluation part of the vestibular software.sth oculomotor and optokinetic stimuli is Simulation of Vestibulo-Ocular Reflex Exercises (SVORE). This system includes Assessment and Rehabilitation departments. The maximum pursuit frequency levels were determined with the measurements.For the evaluation of pursuit eye movement, patient will be asked to focus continuely on the objects on the screen.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients between 18-70 years of age with bilateral vestibular hypofunction and peripheral vestibulopathy
Exclusion Criteria:
  • Patients with unilateral vestibular hypofunction, cerebellar lesion, and cognitive problems were excluded from the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gönül Ertunç Gülçelik Kocaeli̇ Turkey 41030

Sponsors and Collaborators

  • Istanbul Gedik University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gonul ERTUNC GULCELIK, Asst. Prof., Istanbul Gedik University
ClinicalTrials.gov Identifier:
NCT05676307
Other Study ID Numbers:
  • 31207858
First Posted:
Jan 9, 2023
Last Update Posted:
Jan 9, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 9, 2023